Food and Drug Administration approval process for ophthalmic drugs in the US

Purpose of review The purpose of this review is to provide the overall framework of the review and approval of ophthalmic drugs in the US. Recent findings Examples from the recent approval of the ranibizumab injection (Lucentis; Genentech, South San Francisco, California, USA) are offered to illustrate the current approval process at the Food and Drug Administration (FDA). Summary New drugs are brought to the US market after review of the New Drug Application or Biologic License Application by the FDA. This review process requires the teamwork of an interdisciplinary team of clinicians, scientists and regulatory personnel. This team is ultimately responsible for recommending to the Secretary of Health and Human Services (or designee) the approvability of a drug based on defined requirements including the drug's risk/benefit profile, quality and purity, and the drug's ability to be labeled effectively. Within the Center for Drug Evaluation and Research this review team for ophthalmic drugs resides primarily within the Division of Anti-infective and Ophthalmology Products.